510(k) K013521 ยท JAK System, X-Ray, Tomography, Computed
GEMINI IMAGING SYSTEM
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Oct 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2012 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH.
The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Terminated |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Gemini PET/CT sytem, Dual Configuration Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.